ASEptic Manufacturing Expert

hace 4 días


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

Job Title: ASEptic Manufacturing Expert
Reports to: Director of Regulatory Affairs

At Qrc Group Llc, we are committed to delivering exceptional regulatory compliance solutions to our clients. We seek a highly experienced ASEptic Manufacturing Expert to join our team. As a key member, you will be responsible for providing expert regulatory advice, preparing and reviewing regulatory submissions, assessing facility design, staying up-to-date with industry standards, and supporting CAPA plans.

Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with FDA and global regulatory standards.
  • Prepare and review comprehensive regulatory submissions to the FDA, ensuring accuracy and completeness.
  • Assess and advise on the regulatory aspects of facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.
  • Stay current with FDA regulations and industry standards for aseptic processing and pharmaceutical products.
  • Support the preparation and submission of Corrective and Preventive Action (CAPA) plans and responses to regulatory authorities.


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